DyspneaPhase 4NCT05812183
Gastric Sleeve-Induced Weight Loss on Shortness of Breath in Obesity
A Phase 4 study testing Bariatric surgery and Medical weight loss in people with Dyspnea and Quality of Life, run by University of California, Los Angeles.
Trial summary
Most research to date on bariatric surgery outcomes has been about metabolic syndrome, a disorder very effectively treated by bariatric surgery. However, obesity is also associated with many other problems that have received much less attention. Amongst the most troubling of these for patients is dyspnea. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dyspnea, Quality of Life
- What is being tested?
- Bariatric surgery and Medical weight loss
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 9 Jul 2023to 12 Feb 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female ≥18 years of age.
- All patients undergoing gastric sleeve resection for serious obesity at the Ronald Reagan medical center will be considered for enrollment in the experimental group.
- English/Spanish speakers.
- The patients included will be with preserved cognition and a capacity to understand questionnaires.
- Written informed consent (and assent when applicable) obtained from subject and ability for subject to comply with the requirements of the study.
Who cannot join
- Serious cardiovascular disease, previous gastrointestinal surgery, psychological concerns (mental disorders and dementia), recently hospitalized, pulmonary diseases, renal failure, or history of malignancy.
- Undergoing procedures other than gastric sleeve resection or are having these operations after they have had other bariatric procedures.
- Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
- -
About this study
Official title: The Effect of Gastric Sleeve-Induced Weight Loss on Shortness of Breath in Patients with Obesity: a Feasibility Study
Most research to date on bariatric surgery outcomes has been about metabolic syndrome, a disorder very effectively treated by bariatric surgery. However, obesity is also associated with many other problems that have received much less attention. Amongst the most troubling of these for patients is dyspnea. Dyspnea results in substantial patient distress that can greatly reduce health-related quality of life. Little is known about the relationship between dyspnea, weight loss, and bariatric surgery. Dyspnea is a complex symptom that may lead to adaptive responses, such as the need to rest as a consequence of even minimal activity or seeking medical attention. The main outcome of the study will be measured using a new state-of-the-science validated HRQOL measure, the Patient Reported Outcome Measuring Information System for Heart Failure (PROMIS+HF 27).
Read the detailed description
The main purpose of this prospective matched cohort study is to determine the feasibility for a future, novel large-scale study, clinical trial that will aim to determine how common dyspnea is in obese patients, how much dyspnea affects their quality-of-life, and how these parameters are affected by medically or surgically induced weight loss. Our basic assumption is that dyspnea is more common than is commonly believed in obese patients and that it profoundly affects quality of life. Our main hypothesis is that weight loss improves dyspnea and HRQOL and that bariatric surgery induced weight loss is more effective than medical weight loss at improving dyspnea-related quality-of-life.
- Conditions
- Dyspnea, Quality of Life
- Being tested
- Bariatric surgery, Medical weight loss
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryDevice
Gastric sleeve resection will be performed by experienced surgeons. Postoperative care will follow UCLA's postoperative care pathways for gastric sleeve resection.
Medical weight lossDrug
The medical weight loss intervention will follow UCLA's RFO standard protocol. Over a period of 12 months, patients in the medical weight loss group will follow a very low caloric diet (VLCD) at the UCLA RFO program. All study patients will be prescribed a VLCD, an exercise regimen and will participate in group classes on behavioral modification. The caloric intake consists of a commercially prepared meal replacement powder supplying 700-800 cal/day. Each formula packet provides 100kcal and 15g of high biological value protein, and the daily allowance of required minerals and vitamins. Some patients may recieve adjuvant drug therapy including Orlistat (Xenical, Alli), Phentermine-topiramate (Qsymia), Naltrexone-bupropion (Contrave), Liraglutide (Saxenda), Semaglutide (Wegovy), Tirzepatide (Zepbound) or Setmelanotide (Imcivree).
| Study group | Role | What they receive |
|---|---|---|
| Bariatric surgery | Experimental | Gastric sleeve resection will be performed by experienced surgeons. Postoperative care will follow UCLA's postoperative care pathways for gastric sleeve resection. Receives: Device: Bariatric surgery |
| Medical weight loss | Experimental | The medical weight loss intervention will follow the University of California at Los Angeles's (UCLA) Research For Obesity (RFO) standard protocol. Over a period of 12 months, patients in the medical weight loss group will follow a very loc caloric diet (VLCD) at the UCLA RFO program. All study patients will be prescribed a VLCD, an exercise regimen and will participate in group classes on behavioral modification. The caloric intake consists of a commercially prepared meal replacement powder supplying 700-800 cal/day. Each formula packet provides 100kcal and 15g of high biological value protein, and the daily allowance of required minerals and vitamins. Receives: Drug: Medical weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea
Will be assessed using the PROMIS+HF 27 will be administered via RedCap for patients both groups.
PROMIS+HF 27 is part of a National Institutes of Health initiative to develop state-of-the art measures for quality of life. PROMIS+HF 27 contains 3 questions about dyspnea severity. Each of them can be assessed individually or the 3 combined to increase measurement precision into a dyspnea severity domain score.
Measured: 12 months
Secondary outcomes (1)
Health related quality of life
Will be assessed using the PROMIS+HF 27 will be administered via RedCap for patients both groups.
PROMIS+HF 27 is part of a National Institutes of Health initiative to develop state-of-the art measures for quality of life.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start9 Jul 2023
- Primary completion12 Feb 2025 (estimated)
- Study completion12 Feb 2025
Why it stopped: Conducted an interim analysis on similar data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Surgery is comapred with medical treatments for obesity. Some of the medical treatments will include treatments using FDA-approved medications
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Harry Livingston, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812183
- Sponsor's protocol ID
- 22-001915
- Status last verified
- Feb 2025
- First submitted
- 31 Mar 2023
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gastric Sleeve-Induced Weight Loss on Shortness of Breath in Patients with Obesity: a Feasibility Study
- ClinicalTrials.gov ID
- NCT05812183
- Acronym / sponsor ID
- 22-001915
- Conditions
- Dyspnea, Quality of Life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Conducted an interim analysis on similar data
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center, Northwestern University
- Study start
- 9 Jul 2023 (actual)
- Primary completion
- 12 Feb 2025 (estimated)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most research to date on bariatric surgery outcomes has been about metabolic syndrome, a disorder very effectively treated by bariatric surgery. However, obesity is also associated with many other problems that have received much less attention. Amongst the most troubling of these for patients is dyspnea. Dyspnea results in substantial patient distress that can greatly reduce health-related quality of life. Little is known about the relationship between dyspnea, weight loss, and bariatric surgery. Dyspnea is a complex symptom that may lead to adaptive responses, such as the need to rest as a consequence of even minimal activity or seeking medical attention. The main outcome of the study will be measured using a new state-of-the-science validated HRQOL measure, the Patient Reported Outcome Measuring Information System for Heart Failure (PROMIS+HF 27).
Detailed description
The main purpose of this prospective matched cohort study is to determine the feasibility for a future, novel large-scale study, clinical trial that will aim to determine how common dyspnea is in obese patients, how much dyspnea affects their quality-of-life, and how these parameters are affected by medically or surgically induced weight loss. Our basic assumption is that dyspnea is more common than is commonly believed in obese patients and that it profoundly affects quality of life. Our main hypothesis is that weight loss improves dyspnea and HRQOL and that bariatric surgery induced weight loss is more effective than medical weight loss at improving dyspnea-related quality-of-life.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Surgery is comapred with medical treatments for obesity. Some of the medical treatments will include treatments using FDA-approved medications
| Arm | Type | Receives |
|---|---|---|
| Bariatric surgery | Experimental | Device: Bariatric surgeryGastric sleeve resection will be performed by experienced surgeons. Postoperative care will follow UCLA's postoperative care pathways for gastric sleeve resection. |
| Medical weight loss | Experimental | Drug: Medical weight lossThe medical weight loss intervention will follow the University of California at Los Angeles's (UCLA) Research For Obesity (RFO) standard protocol. Over a period of 12 months, patients in the medical weight loss group will follow a very loc caloric diet (VLCD) at the UCLA RFO program. All study patients will be prescribed a VLCD, an exercise regimen and will participate in group classes on behavioral modification. The caloric intake consists of a commercially prepared meal replacement powder supplying 700-800 cal/day. Each formula packet provides 100kcal and 15g of high biological value protein, and the daily allowance of required minerals and vitamins. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female ≥18 years of age.
- All patients undergoing gastric sleeve resection for serious obesity at the Ronald Reagan medical center will be considered for enrollment in the experimental group.
- English/Spanish speakers.
- The patients included will be with preserved cognition and a capacity to understand questionnaires.
- Written informed consent (and assent when applicable) obtained from subject and ability for subject to comply with the requirements of the study.
Key exclusion criteria (4 listed)
- Serious cardiovascular disease, previous gastrointestinal surgery, psychological concerns (mental disorders and dementia), recently hospitalized, pulmonary diseases, renal failure, or history of malignancy.
- Undergoing procedures other than gastric sleeve resection or are having these operations after they have had other bariatric procedures.
- Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric surgeryGastric sleeve resection will be performed by experienced surgeons. Postoperative care will follow UCLA's postoperative care pathways for gastric sleeve resection. | Device | Bariatric surgery |
| Medical weight lossThe medical weight loss intervention will follow UCLA's RFO standard protocol. Over a period of 12 months, patients in the medical weight loss group will follow a very low caloric diet (VLCD) at the UCLA RFO program. All study patients will be prescribed a VLCD, an exercise regimen and will participate in group classes on behavioral modification. The caloric intake consists of a commercially prepared meal replacement powder supplying 700-800 cal/day. Each formula packet provides 100kcal and 15g of high biological value protein, and the daily allowance of required minerals and vitamins. Some patients may recieve adjuvant drug therapy including Orlistat (Xenical, Alli), Phentermine-topiramate (Qsymia), Naltrexone-bupropion (Contrave), Liraglutide (Saxenda), Semaglutide (Wegovy), Tirzepatide (Zepbound) or Setmelanotide (Imcivree). | Drug | Medical weight loss |
Primary outcome
Dyspnea
Time frame: 12 months
Will be assessed using the PROMIS+HF 27 will be administered via RedCap for patients both groups. PROMIS+HF 27 is part of a National Institutes of Health initiative to develop state-of-the art measures for quality of life. PROMIS+HF 27 contains 3 questions about dyspnea severity. Each of them can be assessed individually or the 3 combined to increase measurement precision into a dyspnea severity domain score.
1 secondary outcome
Health related quality of life
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bariatric surgery and Medical weight loss in people with Dyspnea and Quality of Life, run by University of California, Los Angeles.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.